Study of Multiple Doses of Saxagliptin (BMS-477118)

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-477118 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.

Inclusion Criteria:

• Type 2 diabetes who are drug-naive
• Screening HbA1c ≥ 6.8% and ≤ 9.7%
• Screening fasting or random C-peptide > 0.5 ng/mL
• < 35 years old must be negative for anti-GAD antibodies
• Body Mass Index < 35 kg/m2

Exclusion Criteria:

• Symptoms of poorly controlled diabetes
• History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
• Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
• Significant cardiovascular history